scholarly journals Impact of Pituitary Stalk Preservation on Tumor Recurrence/Progression and Surgically Induced Endocrinopathy After Endoscopic Endonasal Resection of Suprasellar Craniopharyngiomas

2021 ◽  
Vol 12 ◽  
Author(s):  
Zhengyuan Chen ◽  
Zengyi Ma ◽  
Wenqiang He ◽  
Xuefei Shou ◽  
Zhao Ye ◽  
...  
Keyword(s):  
Diabetes Insipidus ◽  
Tumor Recurrence ◽  
Progression Free Survival ◽  
Pituitary Stalk ◽  
Endoscopic Endonasal ◽  
Central Type ◽  
Kaplan Meier ◽  
Peripheral Type ◽  
The Impact ◽  
Surgically Induced

Objective: To investigate the factors associated with recurrence/progression after endoscopic endonasal resection of suprasellar craniopharyngiomas. Special attention was paid to assess the impact of pituitary stalk preservation on tumor recurrence/progression and endocrinological outcomes.Methods: We retrospectively recruited 73 patients with suprasellar craniopharyngiomas undergone endoscopic endonasal approach (EEA) surgery from September 2014 to May 2019 and assessed their clinical characteristics, surgical outcomes, and recurrence/progression. Stalk preservation or sacrifice was determined by reviewing operative records, videos, and post-operative magnetic resonance imaging.Results: Gross total resection (GTR) was achieved in 51 cases (69.9%). Tumor recurrence was seen in 5 cases (9.8%) and progression was seen in 8 cases (36.4%), respectively. GTR (OR = 0.248 CI 0.081–0.759; p = 0.015) was the only independent factor influencing recurrence/progression. Kaplan-Meier survival analysis showed that the mean recurrence/progression-free survival were 53 (95% CI 48–59) and 39 (95% CI 28–50) months, respectively, in patients with and without GTR (p = 0.011). Pituitary stalk preservation was more common in cases with peripheral type tumors (83% vs. 30%, p < 0.01). Preserving the pituitary stalk does not appear to decrease the percentage of GTR (75.5% vs. 55.0%, p = 0.089), or increase the rate of tumor recurrence (12.5% vs. 0%, p = 0.508) or progression (46.2% vs. 22.2%, p = 0.486). However, surgically induced hypothyroidism (60.5% vs. 100%, p = 0.041) and diabetes insipidus (35.1% vs. 81.8%, p = 0.017) were significantly lower in patients with stalk preservation. For patients who had hypopituitarism before EEA, there was no difference between those with and without stalk preservation regarding post-operative hypopituitarism (p > 0.05).Conclusion: GTR is the only independent predictor of recurrence/progression after EEA surgery for suprasellar craniopharyngiomas. Preserving the pituitary stalk does not appear to increase the risk of non-GTR and tumor recurrence/progression and might help reduce the risk of surgically induced hypothyroidism and diabetes insipidus. We recommend preserving the pituitary stalk in peripheral type suprasellar craniopharyngiomas with normal pituitary function, especially in cases without hypothyroidism or diabetes insipidus. On the other hand, stalk sacrifice could be considered in central type tumors with severe pre-operative endocrinopathy.

Comparative study of six cycles versus twelve cycles of adjuvant temozolomide post concurrent chemoradiation in newly diagnosed glioblastoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e13034-e13034
Author(s):  
Menal Bhandari ◽  
Ajeet K Gandhi ◽  
Pramod Kumar Julka ◽  
Chitra Sarkar ◽  
Dayanand Sharma ◽  
...  
Keyword(s):  
Univariate Analysis ◽  
Progression Free Survival ◽  
Extent Of Resection ◽  
Rank Test ◽  
Karnofsky Performance Score ◽  
Free Survival ◽  
Kaplan Meier ◽  
The Impact ◽  
Mib 1

e13034 Background: This study assesses the impact of 6 cycles of adjuvant TMZ (conventional arm) versus 12 cycles (Extended arm) on Progression free survival (PFS), evaluate the toxicity and correlate the outcome with EGFR, P53 and MIB I labelling Index. Methods: Between December 2010 to October 2012, 36 post operative patients of Glioblastoma between age 18-65 years and Karnofsky Performance Score (KPS) ≥ 70 were included. Patients were randomized to receive Radiation with a dose of 60 Gray in 30 fractions over 6 weeks at 2 gray/fraction with concomitant TMZ (75 mg/m2/day) and Adjuvant therapy with either 6 or 12 cycles of TMZ(150 mg/m2 for 5 days, 28 days cycle). Patients were then assessed monthly clinically and imaged with MRI/CT every 3 monthly or when symptomatic. Toxicity was assessed using CTCAE version 3.0. Statistical Analysis was done using SPSS version 17.0.Kaplan Meier method was used for analysis of survival and log rank test was used for assessing the impact of variables on survival. Results: Of 36 patients, 18 patients were treated in each arm. Median age and KPS in both the arms was 47 years and 80 respectively. 44 % patients in the conventional arm and 50% patients in the Extended arm underwent complete surgical resection. 22% patients in the conventional arm and 28% in the extended arm did not complete their intended treatment. Grade ¾ Thrombocytopenia was seen in 16% in the extended arm and 0% in the conventional arm.EGFR, P 53 and MIB 1 >20% was seen in 26%, 45% and 20% patients respectively, overall. Median follow up was 18 months for both the arms (Range 10-23 months).At last follow up,8 patients in each arm had progression. Median PFS was 10 months vs.18.4 months (p 0.47) in conventional and extended arm respectively. On Univariate analysis, patients with KPS ≤ 80 had poorer survival than those >80 (Median PFS 9.5 Months vs. 16.9 Months; p 0.02).Age, extent of resection, EGFR, P53, MIB 1 did not significantly alter survival in the two treatment groups. Conclusions: Our study showed that schedule of extended Temozolomide is well tolerated by patients and tend to have better progression free survival. Further prospective randomized studies are needed to validate the findings of our study.

Does Gleason score (GS) predict efficacy of abiraterone acetate (AA) therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)? An analysis of AA phase 3 trials.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 20-20 ◽  
Author(s):  
Karim Fizazi ◽  
Thomas W. Flaig ◽  
Carsten-Henning Ohlmann ◽  
Howard I. Scher ◽  
Johann Sebastian De Bono ◽  
...  
Keyword(s):  
Clin Oncol ◽  
Cox Model ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Abiraterone Acetate ◽  
Initial Diagnosis ◽  
Castration Resistant Prostate Cancer ◽  
Treatment Benefit ◽  
Kaplan Meier ◽  
The Impact

20 Background: GS is strongly prognostic in localized PC but is less so in mCRPC (Halabi S, J Clin Oncol 2003; Armstrong AJ, Eur J Cancer 2010). Pts with high-risk localized PC and high GS who undergo radiation therapy benefit from long-term androgen deprivation therapy (Horwitz EM, J Clin Oncol 2008). In mCRPC, the impact of GS at initial diagnosis on response to AA therapy is unknown. We retrospectively evaluated efficacy outcomes in pts with mCRPC treated with AA plus prednisone (P) vs P alone in pivotal studies COU-AA-301 (post-docetaxel) and COU-AA-302 (chemo-naive) by GS (≥ 8 or < 8). Methods: 1,048 pts in COU-AA-301 and 996 in COU-AA-302 with mCRPC treated with AA 1 g + P 5 mg po BID or placebo + P had GS data at diagnosis. Efficacy end points evaluated: overall survival (OS), radiographic progression free survival (rPFS), and time to prostate-specific antigen progression (TTPP) (de Bono JS, NEJM 2011; Fizazi K, Lancet Oncol 2012; Ryan CR, NEJM 2013). Distributions and medians were estimated by the Kaplan-Meier method, and hazard ratio (HR) and 95% confidence interval were estimated by the Cox model. Results: Proportion of pts with GS ≥ 8 and GS < 8 was similar across treatment groups and studies. Outcomes by GS are summarized in the Table. Conclusions: GS (≥ 8 or < 8) at initial diagnosis was not predictive of treatment benefit of AA + P vs P alone in post-docetaxel and chemo-naïve pts with mCRPC, with both groups benefiting. In this era of novel androgen signaling targeted agents, GS may not be relevant in predicting efficacy with AA for pts with mCRPC. Clinical trial information: NCT00638690, NCT00887198. [Table: see text]

Activity of third line (3L) therapy in patients with metastatic non-clear-cell renal cell carcinoma (mnccRCC).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 650-650
Author(s):  
Annalisa Guida ◽  
Gwénaël Le Teuff ◽  
Emeline Colomba ◽  
Carolina Alveosta Silva ◽  
Flore Salviat ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
Cell Renal Cell Carcinoma ◽  
Poor Risk ◽  
Retrospective Data Analysis ◽  
Kaplan Meier ◽  
The Impact

650 Background: Medical treatment of patients (pts) with mnccRCC remains uncertain, with no established standard treatment. In addition, no data on late line of treatment have been reported. The aim of this study was to investigate clinical outcome for patients receiving 3L therapy in mnccRCC Methods: Retrospective data analysis was performed using the IGRECC (Institut Gustave Roussy REnal Cell Carcinoma) database to describe clinical features and outcomes of 3L therapy in mnccRCC pts. Kaplan Meier estimation was applied for progression-free survival (PFS) and overall survival (OS) Results: Out of all pts with mRCC treated with a targeted therapy from 2005 to 2016, 202/1027 (20%) had mnccRCC. 117 (58%) received 2L therapy and 62 (30%) received 3L therapy. These pts had papillary RCC (61%), unclassified RCC (19), Xp11translocation renal cell carcinoma (13%) and chromophobe tumors (7%). The most common 3L therapies were: everolimus (29%), sorafenib (18%), other drugs in clinical trials (16%), sunitinib (11%), axitinib (10%) and cabozantinib (10%). Baseline characteristics are displayed in Table 1. With a median follow-up of 47 months (mo) (min: 0.7 max: 74), the median PFS is 5 mo (95%CI 2.7 - 5.8) and the median OS is 11.7 mo (95%CI 10 - 20). Pts with a favourable, intermediate and poor risk International Metastatic Renal Cell Cancer Database Consortium (IMDC) score had a median OS of 21 mo (95%CI 8 – NR), 11.9 mo (95%CI 10 – 25), and 6.2 mo (95%CI 2 – 8), respectively (p < 0.0001). One patient (2%) obtained a partial response and 26 pts (51%) achieved a stable disease, among 51 evaluable pts Conclusions: This is the first report investigating the impact of 3L systemic therapy in a rare population. Selected pts could benefit of more lines of therapy and IMDC score appears to stratify well prognostic groups, especially poor risk patients. [Table: see text]

Project Switch: Docetaxel as a potential synthetic control in metastatic non-small cell lung cancer (mNSCLC) trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9105-9105 ◽  
Author(s):  
Michael E. Menefee ◽  
Yutao Gong ◽  
Pallavi Shruti Mishra-Kalyani ◽  
Rajeshwari Sridhara ◽  
Bindu Kanapuru ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Progression Free Survival ◽  
Experimental Therapy ◽  
Synthetic Control ◽  
Small Cell Lung ◽  
Free Survival ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Real World Evidence ◽  
The Impact

9105 Background: Docetaxel is a common comparator arm to test novel therapies in post-platinum mNSCLC trials. The advent of Real World Evidence (RWE) has renewed interest in the use of synthetic control arms (control arms from previously conducted randomized trials) to improve accrual to trials and increase patient access of promising experimental agents. We reviewed legacy second-line (2L) mNSCLC trials to assess the impact of switching docetaxel control arms from one trial to another and compare to an experimental regimen. Methods: We identified 5 contemporary 2L trials that enrolled 2013 patients receiving an experimental therapy vs. docetaxel: 5 immunoncology head-to-head trials (one with 2 arms) and one anti-VEGF add-on trial. Kaplan-Meier curves of overall survival (OS) and progression-free survival (PFS) were produced for docetaxel controls. We calculated OS and PFS hazard ratios and 95% confidence intervals for each synthetic trial. A pooled doc arm was also compared with each experimental agent. Results: See Table. Conclusions: Both individual and pooled docetaxel switching of control arms approximated the original OS HR and 95% CI. Methods such as bootstrapped sampling and propensity score matching will be performed in an effort to more closely approximate the original trial characteristics. [Table: see text]

scholarly journals Impact of Early Switching to Nilotinib As Second Line TKI in Patients with Chronic Myeloid Leukemia Who Were Intolerant to, Suboptimal to and Failed Imatinib: The Thai Multi-Centered Study

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4267-4267
Author(s):  
Pongtep Viboonjuntra ◽  
Arnuparp Lekhakula ◽  
Kanchana Chansung ◽  
Chittima Sirijerachai ◽  
Pimjai Niparuck ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Real Life ◽  
Progression Free Survival ◽  
Second Line ◽  
Free Survival ◽  
Kaplan Meier ◽  
Grade 3 ◽  
The Impact

Abstract Introduction : To date, the ELN recommendation and NCCN guidelines are the principle mile stones to follow up the treatment response and to make the decision of TKIs switching. However, in real life practice, many factors influence changing the real switching date from the date had an indication. This study aims to analyze the impact of early switching to second line TKI, nilotinib, in real life practice, for the CML patients who failed, had sub-optimal response or were intolerant to imatinib. Methods : This prospective study was conducted through 7 medical centers in Thailand between 1st of September 2009 and 31st of August 2011. Adult CML patients of age ≥ 18 years old, in chronic and accelerated phase, who had failure, suboptimal response or intolerance to imatinib, based on ELN 2009 guideline, were included and were eligible with nilotinib 400 mg twice daily. Prospective data collection for 24 months of each patient was performed. The main objective was to identify the impact of early switching to nilotinib on major molecular response (MMR). The other objectives were to observe the efficacy of nilotinib including overall survival, progression free survival and the safety. The survival results were presented as Kaplan-Meier survival curves. For the comparison of the treatment groups, the Kaplan-Meier estimator with the corresponding log-rank test for equality of survivor functions across treatment group was applied. Results : The final 108 cases were analysed. The median age was 47 (17-79) years with the proportion of male to female of 1.4:1 respectively. The median duration of the prior imatinib treatment was 18 months (2-142 months). The median duration between the date of indication and the date of real switching was 3.1 months (0-62.8 months) with 50% changing less than 3 months, 26.9% between 3 months and 12 months, and 23.1% changing longer than 12 months. The indication of switching included 63.6% failure to imatinib, 29% intolerance to imatinib and 7.4% suboptimal to imatinib. On the nilotinib switching, 70.4% completed 24 months follow-up, and 29.6% discontinued treatment mostly because of unsatisfactory results or adverse events. Evaluation was made every 3 months based on 2009 ELN recommendation. At 3 months, 57%, 20%, and 8% of the patients achieved CHR, CCyR and MMR, respectively. Those who did not achieve CHR at 3 months never achieved MMR, while 86 % of those who achieved CCyR at 3 months achieved MMR. All CML achieving MMR at 3 months had sustained MMR throughout the study period (24 months). Imatinib suboptimal response had better outcome than imatinib failure and imatinib intolerance groups. A preliminary analysis of BCR-ABL mutation was performed on 90 cases, and mutations were found on 21 cases. Two of them were T315I which were excluded from the study. The cases with mutation had poorer response to treatment than those without mutation. There was one case with initial G250E mutation developing T315I mutation after treatment with nilotinib. At 24 months, one case progressed to accelerated phase and 3 cases progressed to blastic transformation. The 2-year overall survival and 2-year progression-free survival and were 98.9% and 96.9% (figure 1 and 2), respectively. The interquatile analysis was done to identify the groups of cumulative MMR according to the duration between the date of indication and the date of real switching to nilotinib. The patients who switched to nilotinib within 12 months after date of indication could have a greater chance to achieved MMR than those who switched treatment later than 12 months (p(log-rank) = 0.002) (figure 3). Skin rash, musculoskeletal pain, and infection were the three most common non-hematologic adverse events, However, most of them were grade 1-2, except for 4 cases with grade 3-4 infections. Grade 3-4 hematologic adverse events included thrombocytopenia (12%), neutropenia (11%), anemia (5%) and leucopenia (4%), and most of them were manageable. Although biochemical abnormalities were commonly found, most of them were mild. Conclusions : Nilotinib, as a second line treatment showed excellent efficacy and tolerability. Indication for nilotinib treatment, initial mutation status and depth of response at 3 months after treatment can predict outcomes of the patients. However, the patients will have a greater chance to achieve MMR if they switched to nilotinib within 12 months after the date of indication for changing. Disclosures No relevant conflicts of interest to declare.

Doxorubicin and concurrent radiotherapy for anaplastic thyroid cancer: We need to do better

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 16506-16506 ◽  
Author(s):  
S. Lim ◽  
N. Y. Lee ◽  
M. G. Fury ◽  
R. A. Ghossein ◽  
A. R. Shaha ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Progression Free Survival ◽  
Anaplastic Thyroid Cancer ◽  
Median Number ◽  
Cancer Center ◽  
Published Data ◽  
Histologic Subtype ◽  
Kaplan Meier ◽  
Prior Surgery ◽  
The Impact

16506 Background: Anaplastic thyroid cancer (ATC) is a rare, aggressive malignancy. The potential for pathologic misclassification complicates the interpretation of published data. One treatment option for locoregionally (LR) advanced disease is weekly low-dose doxorubicin (D) with concurrent radiation therapy (RT), based on reported 2-year local control rates of 68% (ATC)/77% (other TC histologic subtypes) (Cancer 1987;60:2372). We looked to evaluate our experience with this general approach, but in a larger series which included pathologic confirmation of all ATC cases. Methods: Patients (pts) were identified through the Memorial Sloan-Kettering Cancer Center (MSKCC) Radiation Oncology and Pathology Databases. Inclusion criteria: diagnosis of ATC between 1984–2006, with pathology review at MSKCC; LR disease only, able to be encompassed within a RT portal; treatment at MSKCC with planned weekly D (10 mg/m2) and concurrent radiation. Prior surgery was allowed. Documentation of failure was based on clinical/radiographic assessment. Principal outcomes assessed: LR control (LRC: no failure at the primary site, in the neck, or the mediastinum), progression-free survival (PFS), and overall survival (OS). The Kaplan-Meier method was applied. Results: Thirty-seven patients were included in our analysis (median age 64; 54% female, 46% male). Median RT dose 5760 cGy, >4500 cGy in 32 (87%), administered through hyperfractionated or once-daily schedules. Median number of D treatments received 5.5, >4 in 24 (65%). 2-year outcomes: LRC 25%; PFS 8%; OS 18%. 6 patients remain alive at the time of last follow-up with survival durations of 4.1, 11.4, 11.7, 57.3, 58.5, and 140.7 months, respectively. A subset analysis was performed limited to the 24 patients (65%) who completed >4,500 cGy of radiation and >4 doses of D. 2-year outcomes were improved in this latter group, but remained disappointing, even among these more highly selected pts (LRC 30%; PFS 11%; OS 27%). Conclusions: Better therapy is needed for this poor prognostic disease. Future analyses will evaluate the impact of histologic subtype of ATC, radiation technique/dose, and surgical resection on outcome. No significant financial relationships to disclose.

Progression free survival and time to local failure after radiosurgery of pleural metastases in twenty-two patients with thymomas.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8565-8565
Author(s):  
Giulia Pasquini ◽  
Antonio Chella ◽  
Claudia Menichelli ◽  
Marco Lucchi ◽  
Maria Grazia Fabrini ◽  
...  
Keyword(s):  
Surgical Resection ◽  
Stereotactic Body Radiation Therapy ◽  
Progression Free Survival ◽  
Local Failure ◽  
Stage At Diagnosis ◽  
Common Site ◽  
Free Survival ◽  
Kaplan Meier ◽  
Pleural Metastases ◽  
The Impact

8565 Background: Thymomas but not thymic carcinomas can benefit of cytoreductive surgery even if a complete resection is not achievable. Surgical resection of pleural metastases, the most common site of progression, can be performed in selected patients. We evaluated the outcome of stereotactic body radiation therapy (SBRT) for treatment of pleural metastases in patients’ not eligible for surgery. Methods: We retrospectively identified 22 patients treated with SBRT for pleural metastases between 2004 and 2019. According to RECIST criteria, time to local failure and progression free survival (PFS) were calculated using Kaplan-Meier estimation. Results: Twelve of the 22 patients were male. The median age was 40 years (range 29-73). There were 1 A, 3 AB, 3 B1, 3 B2, 3 B2/B3 and 9 B3 thymomas. The Masaoka stage at diagnosis was IIA in 2, IIB in 7, III in 5, IVA in 7 and IVB in 1 patient. Pleural metastases and primary tumor were synchronous in 8 patients. Thymectomy was performed in 21 patients. Seven patients received pre-operative chemotherapy and 12 post-operative radiotherapy. One patient received chemotherapy and radiotherapy after a macroscopically incomplete thymectomy. Five patients had a single pleural metastatic site and 17 presented multiple localizations. Sixteen patients received SBRT on multiple sites of pleural metastases. At the time of the analysis a patient received SBRT exclusively on one of 3 pleural metastases. The median dose of radiation was 30Gy (range 25-40) given in 3 fractions. Ten patients experienced a progression of treated lesions with a median time to local failure of 25.5 months (95%CI 20.9-30.1). The median PFS was 20.4 months (95%CI 10.7-30). There were not significant differences in PFS between patients diagnosed with synchronous and metachronous metastases (p=0.477), across those treated with chemotherapy or naive (p=0.189) and between those who received or not a previous surgical resection of the pleural metastases (p=0.871). Conclusions: SBRT of pleural metastases is feasible and offer an interesting local control of diseases. The impact of this treatment on patients’ survival is hardly predictable because of the heterogenous clinical behavior of thymomas.

scholarly journals SURG-12. PREDICTORS OF SURVIVAL AND UTILITY OF INTRAOPERATIVE MRI FOR RESECTION OF GRADE II ASTROCYTOMAS AND OLIGODENDROGLIOMAS: A MULTICENTER ANALYSIS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii205-ii206
Author(s):  
Alexander Yahanda ◽  
Bhuvic Patel ◽  
Amar Shah ◽  
Daniel Cahill ◽  
Garnette Sutherland ◽  
...  
Keyword(s):  
Tumor Resection ◽  
Progression Free Survival ◽  
Extent Of Resection ◽  
Intraoperative Mri ◽  
Patient Treatment ◽  
Subtotal Resection ◽  
Related Factors ◽  
Kaplan Meier ◽  
Grade Ii ◽  
The Impact

Abstract BACKGROUND Few studies use large, multi-institutional patient cohorts to examine the role of intraoperative MRI (iMRI) in the resection of grade II gliomas. We assessed the impact of iMRI and other factors on overall survival (OS) and progression-free survival (PFS) for newly-diagnosed grade II astrocytomas and oligodendrogliomas. METHODS Retrospective analyses of a multicenter database assessed the impact of patient-, treatment-, and tumor-related factors on OS/PFS. RESULTS 232 resections (112 astrocytomas, 120 oligodendrogliomas; 135 males; mean age 36.2 ± 0.9 years) were analyzed. Oligodendrogliomas had longer OS (p&lt; 0.001) and PFS (p=0.009) than astrocytomas. Multivariate regression showed that extent of resection (EOR), including gross-total (GTR) versus near-total (NTR) resection (p=0.02, HR: 0.64, 95% CI: 0.25-.79) and GTR versus subtotal resection (STR) (p=0.006, HR: 0.23, 95% CI: 0.08-0.66), was associated with longer OS. GTR versus NTR (p=0.04, HR: 0.49, 95% CI: 0.29-.85), GTR versus STR (p=0.02, HR: .54, 95% CI: .32-.91) and iMRI use (p=0.02, HR: 0.54, 95% CI: 0.32-0.92) were associated with longer PFS. Frontal (p=0.048, HR: 2.11, 95% CI: 1.01-4.43) and occipital/parietal (p=0.003, HR: 3.59, 95% CI: 1.52-8.49) locations were associated with shorter PFS (versus temporal). Kaplan-Meier analyses showed longer OS with increasing EOR (p=0.03) and 1p/19q gene deletions (p=0.02). PFS improved with increasing EOR (p=0.01), GTR versus NTR (p=0.02), and resections above STR (p=0.04). Factors influencing adjuvant treatment (35.3% of patients) included age (p=0.002, OR: 1.04) and EOR (p=0.037, OR: 0.41 for NTR versus STR; p=0.003, OR: 0.39 for GTR versus STR), but not glioma subtype or location, as determined by logistic regression. Additional tumor resection after iMRI was performed in 105/159 (66%) iMRI cases, yielding GTR in 54.5% of these cases. CONCLUSIONS EOR significantly improves OS and PFS for patients with grade II astrocytomas and oligodendrogliomas. Intraoperative MRI may improve EOR and was associated with increased PFS.

scholarly journals Impact of Informative Censoring on the Kaplan-Meier Estimate of Progression-Free Survival in Phase II Clinical Trials

2014 ◽  
Vol 32 (27) ◽  
pp. 3068-3074 ◽  
Author(s):  
Federico Campigotto ◽  
Edie Weller
Keyword(s):  
Treatment Failure ◽  
Phase Ii ◽  
Progression Free Survival ◽  
Informative Censoring ◽  
Phase Iii ◽  
Inadequate Response ◽  
Phase Ii Trials ◽  
Free Survival ◽  
Kaplan Meier ◽  
The Impact

Informative censoring in a progression-free survival (PFS) analysis arises when patients are censored for initiation of an effective anticancer treatment before the protocol-defined progression, and these patients are at a different risk for treatment failure than those who continue on therapy. This may cause bias in the estimated PFS when using the Kaplan-Meier method for analysis. Although there are several articles that discuss this issue from a theoretical perspective or in randomized phase III studies, there are little data to demonstrate the magnitude of the bias on the estimated quantities from a phase II trial. This article describes the issues by using two oncology phase II trials as examples, evaluates the impact of the bias using simulations, and provides recommendations. The two trials were selected because they demonstrate two different reasons for censoring. Simulations show that the magnitude of the bias depends primarily on the proportion of patients who are informatively censored and secondarily on the hazard ratio between the group of patients who remain on study and the group of patients who are informatively censored. Recommendations include using an alternative end point, which includes inadequate response and initial signs of clinical progression as treatment failure, and a competing risk analysis for studies in which competing events preclude or modify the probability of observing the primary event of interest. If informative censoring cannot be avoided, then all patients should be observed until progression, and sensitivity analyses should be used as appropriate.

scholarly journals Complete endoscopic resection of a pituitary stalk epidermoid cyst using a combined infrasellar interpituitary and suprasellar endonasal approach: case report

2018 ◽  
Vol 128 (2) ◽  
pp. 437-443 ◽  
Author(s):  
Ana C. I. Nakassa ◽  
Joseph D. Chabot ◽  
Carl H. Snyderman ◽  
Eric W. Wang ◽  
Paul A. Gardner ◽  
...  
Keyword(s):  
Diabetes Insipidus ◽  
Epidermoid Cyst ◽  
Residual Tumor ◽  
Mass Effect ◽  
Visual Disturbance ◽  
Primary Hypothyroidism ◽  
Complete Resection ◽  
High Rate ◽  
Pituitary Stalk ◽  
Endoscopic Endonasal

Intracranial epidermoid cysts are benign lesions of epithelial origin that most frequently present with symptoms of mass effect. Although they are often associated with a high rate of residual tumor and recurrence, maximal safe resection usually leads to good outcomes. The authors report a complete resection of an uncommon pituitary stalk epidermoid cyst with intrasellar extension using a combined suprasellar and infrasellar interpituitary, endoscopic endonasal transsphenoidal approach. The patient, a 54-year-old woman, presented with headache, visual disturbance, and diabetes insipidus. Postoperatively, she reported improvement in her visual symptoms and well-controlled diabetes insipidus using 0.1 mg of desmopressin at bedtime and normal anterior pituitary gland function. One year later, she continues to receive the same dosage of desmopressin and is also taking 50 mcg of levothyroxine daily after developing primary hypothyroidism unrelated to the surgical procedure. A combined infrasellar interpituitary and suprasellar approach to this rare location for an epidermoid cyst can lead to a safe and complete resection with good clinical outcomes.

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